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Ra SW, Kim SY, Lim YY, et al. The safety and efficacy of CKD-497 in patients with acute upper respiratory tract infection and bronchitis symptoms: a multicenter, double-blind, double-dummy, randomized, controlled, phase II clinical trial. J Thorac Dis. 2021;13(1):1-9doi: 10.21037/jtd-20-1567.
Ra, S. W., Kim, S. Y., Lim, Y. Y., Park, S. J., Rhee, C. K., Kim, D. K., Park, Y. B., Lee, C. Y., Yoon, H. K., Park, J. W., & Yoo, K. H. (2021). The safety and efficacy of CKD-497 in patients with acute upper respiratory tract infection and bronchitis symptoms: a multicenter, double-blind, double-dummy, randomized, controlled, phase II clinical trial. Journal of thoracic disease, 13(1), 1-9. https://doi.org/10.21037/jtd-20-1567
Ra, Seung Won, et al. "The safety and efficacy of CKD-497 in patients with acute upper respiratory tract infection and bronchitis symptoms: a multicenter, double-blind, double-dummy, randomized, controlled, phase II clinical trial." Journal of thoracic disease vol. 13,1 (2021): 1-9. doi: https://doi.org/10.21037/jtd-20-1567
Ra SW, Kim SY, Lim YY, Park SJ, Rhee CK, Kim DK, Park YB, Lee CY, Yoon HK, Park JW, Yoo KH. The safety and efficacy of CKD-497 in patients with acute upper respiratory tract infection and bronchitis symptoms: a multicenter, double-blind, double-dummy, randomized, controlled, phase II clinical trial. J Thorac Dis. 2021 Jan;13(1):1-9. doi: 10.21037/jtd-20-1567. PMID: 33569179; PMCID: PMC7867795.
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J Thorac Dis. 2021 Jan;13(1):1-9. doi: 10.21037/jtd-20-1567.

The safety and efficacy of CKD-497 in patients with acute upper respiratory tract infection and bronchitis symptoms: a multicenter, double-blind, double-dummy, randomized, controlled, phase II clinical trial.

Journal of thoracic disease

Seung Won Ra, Sun Young Kim, Yun Young Lim, Shin Jung Park, Chin Kook Rhee, Deog Kyeom Kim, Yong Bum Park, Chang Youl Lee, Hyoung Kyu Yoon, Jeong-Woong Park, Kwang Ha Yoo

Affiliations

  1. Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
  2. Department of Botanical Drug, Chong Kun Dang (CKD) Pharm Research Institute, Yongin-si, Gyeonggi-do, Korea.
  3. Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  4. Department of Internal Medicine, Seoul National University Seoul Metropolitan Government Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
  5. Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Hallym University Medical Center, Seoul, Korea.
  6. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University Medical Center, Chuncheon, Korea.
  7. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Yeouido St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  8. Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
  9. Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.

PMID: 33569179 PMCID: PMC7867795 DOI: 10.21037/jtd-20-1567

Abstract

BACKGROUND: Acute upper respiratory tract infection (AURI) together with acute bronchitis is the most common illness worldwide. Botanical medicines used as expectorants and antitussives have proven to be effective while also having excellent safety margins. We aimed at evaluating the efficacy and safety of a new botanical drug, CKD-497, in patients with AURI and acute bronchitis.

METHODS: In this phase 2 study, 225 patients were enrolled and randomly assigned to one of four treatment groups: placebo (n=55), Synatura

RESULTS: Between baseline and day 7, the mean BSS scores decreased significantly in each group (P<0.001): -4.04±1.85, -4.31±1.47, -4.09±1.48, and -4.28±1.69. However, neither the CKD-497 nor Synatura

CONCLUSIONS: CKD-497 and even the positive control drug had no significant effect on BSS change in this phase 2 clinical trial. However, CKD-497 300 mg had a mild but significant clinical improvement in early bronchitis patients with more severe phlegm. Considering both efficacy and safety, a future study using 300 mg of CKD-497 with a shorter-term endpoint is warranted in patients with more severe bronchitis symptoms.

2021 Journal of Thoracic Disease. All rights reserved.

Keywords: Acute respiratory tract infection; CKD-497; bronchitis; bronchitis severity score (BSS)

Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/jtd-20-1567). Dr. SYK, Dr. PhD. YYL and Ms. SJP report personal fees from C

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